Nuvation Bio announced that the FDA granted Fast Track Designation to its investigational drug, safusidenib. The treatment targets IDH1-mutant glioma, a form of brain cancer. This designation expedites the development and review of therapies addressing serious conditions and unmet medical needs.
Positive results from a Phase 2 study supported the FDA's decision. The trial demonstrated a confirmed objective response rate of 51.9%. It also reported a 79.1% progression-free survival rate at the 36-month mark. These results followed a median follow-up of 38.8 months.
Nuvation Bio is currently enrolling patients in a pivotal Phase 3 trial. This study will further evaluate the efficacy and safety of safusidenib.